Guidance for Industry and Food and Drug Administration Staff on Application User Fees for Combination Products; Availability, 20758-20759 [05-7947]
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Federal Register / Vol. 70, No. 76 / Thursday, April 21, 2005 / Notices
the Center for Devices and Radiological
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Dated: April 13, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–7948 Filed 4–20–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0410]
Guidance for Industry and Food and
Drug Administration Staff on
Application User Fees for Combination
Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
and FDA staff entitled ‘‘Application
User Fees for Combination Products.’’
This document provides guidance to
industry and FDA staff on marketing
application user fees for combination
products. The guidance also describes
how the ‘‘barrier to innovation’’ waiver
provision under the prescription drug
user fee provisions of the Federal Food,
Drug, and Cosmetic Act (the act) may be
applied to innovative combination
products in the infrequent situation
where FDA requires the submission of
two marketing applications.
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
copies of this guidance to the Office of
Combination Products (HFG–3), 15800
Crabbs Branch Way, Rockville, MD
20855, or FAX: 301–427–1935. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments
concerning this guidance to the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to
https://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT:
Mark D. Kramer, Office of Combination
Products (HFG–3), Food and Drug
Administration, 15800 Crabbs Branch
Way, Rockville, MD 20855, 301–427–
1934.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry and FDA staff
entitled ‘‘Application User Fees for
Combination Products.’’ In the Federal
Register of September 28, 2004 (69 FR
57942), FDA issued a notice of
PO 00000
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availability of a draft guidance
document covering the same topic.
As defined under 21 CFR 3.2(e), a
combination product is a product
comprised of any combination of a drug
and a device; a biological product and
a device; a drug and a biological
product; or a drug, device, and a
biological product. Depending upon the
type of combination product, approval,
clearance, or licensure may be obtained
through submission of a single
marketing application, or through
separate marketing applications for the
individual constituent parts of the
combination product. For most
combination products, a single
marketing application is sufficient for
the product’s approval, clearance, or
licensure. In some cases, two marketing
applications may be submitted for a
combination product when one
application would suffice. For example,
a sponsor may choose to submit two
applications when one would suffice in
order to receive some benefit from
having two applications. In other cases,
FDA may determine that two marketing
applications are necessary.
In 1992, Congress passed the
Prescription Drug User Fee Act
(PDUFA). PDUFA authorized FDA to
collect fees from companies that
produce certain human drug and
biological products. The Medical Device
User Fee and Modernization Act of 2002
amended the act to provide for user fees
for the review of device applications.
When a company requests approval of a
new drug, device, or biological product
prior to marketing, it must submit an
application along with a fee to support
the review process.
This document provides guidance to
industry and FDA staff on marketing
application user fees for combination
products. The guidance document
explains that combination products for
which a single marketing application is
submitted, should be assessed the user
fee associated with that particular type
of marketing application. The document
explains that if a sponsor chooses to
submit two marketing applications
when one would suffice, a user fee for
each application would ordinarily be
assessed. The document also explains
that in the infrequent situation where
FDA requires two marketing
applications for a combination product,
two application fees would ordinarily
be assessed. However, the guidance also
describes how the PDUFA ‘‘barrier to
innovation’’ waiver provision may be
applied to innovative combination
products for which FDA requires the
submission of two marketing
applications. Such a waiver would
provide a reduction in application user
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21APN1
Federal Register / Vol. 70, No. 76 / Thursday, April 21, 2005 / Notices
fees equivalent to the additional fee
burden associated with the submission
of two marketing applications. This
guidance does not address how FDA
should determine whether a single or
multiple marketing applications should
be submitted for a combination product.
Such guidance is in development and
will be provided separately for public
review and comment.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Significance of Guidance
AGENCY:
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on application user
fees for combination products. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding the guidance at any
time. Submit two paper copies of any
mailed comments, except that
individuals may submit one copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The guidance
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/oc/combination or by emailing the Office of Combination
Products at combination@fda.gov.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: April 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7947 Filed 4–20–05; 8:45 am]
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Food and Drug Administration
[Docket No. 2004D–0041]
Guidance for Industry on Providing
Regulatory Submissions in Electronic
Format—Content of Labeling;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Content of Labeling.’’ This guidance is
one in a series of guidance documents
on providing regulatory submissions to
FDA in electronic format. FDA’s
regulations require that the content of
labeling for marketing applications be
submitted in electronic format in a form
that FDA can process, review, and
archive. The guidance provides
information on submitting the content
of labeling in electronic format for
review with new drug applications
(NDAs), abbreviated new drug
applications (ANDAs), and biological
license applications (BLAs) for
biological products that meet the
definition of drug in the Federal Food,
Drug, and Cosmetic Act.
DATES: Submit written or electronic
comments on agency guidances at any
time. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857 or to the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
Submit telephone requests to 800–835–
4709 or 301–827–1800.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
PO 00000
Frm 00030
Fmt 4703
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20759
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Randy Levin, Center for Drug Evaluation
and Research (HFD–001), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857,301–
594–5411, e-mail:
levinr@cder.fda.gov, or
Robert Yetter, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852, 301–827–0373.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December
11, 2003 (68 FR 69009), FDA published
a final regulation (the electronic labeling
regulation), which requires the
submission of the content of labeling in
electronic format for marketing
applications. The requirements of the
electronic labeling rule can be found in
§ 314.50(l) (21 CFR 314.50(l)) for NDAs,
§ 314.94(d) for ANDAs, § 601.14(b) for
BLAs, and § 314.81(b) for annual reports
on marketing applications. The
regulations specify that the content of
labeling must be submitted
electronically in a form that FDA can
process, review, and archive. The
regulations also state that FDA will
periodically issue guidance on how to
provide the electronic submission.
II. The Guidance
FDA is announcing the availability of
a guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Content of
Labeling.’’ The guidance provides
information on how to submit the
content of labeling in electronic format.
In the preambles of the proposed and
final rules on electronic labeling, FDA
identified portable document format
(PDF) as the only type of electronic file
format that the agency has the ability to
accept for processing, reviewing, and
archiving. Recent recommendations
from the Institute of Medicine and the
National Committee on Vital and Health
Statistics and mandates in the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (Public Law
108–173) have created a new role for
electronic labeling information.
Electronically formatted content of
labeling will be used to support Federal
health information management
initiatives such as electronic
prescribing; the electronic health record
(EHR), which will provide health care
providers, patients, and other
authorized users access to patient
information in electronic format; and
E:\FR\FM\21APN1.SGM
21APN1
]]>Agencies
[Federal Register Volume 70, Number 76 (Thursday, April 21, 2005)]
[Notices]
[Pages 20758-20759]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7947]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0410]
Guidance for Industry and Food and Drug Administration Staff on
Application User Fees for Combination Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry and FDA staff entitled
``Application User Fees for Combination Products.'' This document
provides guidance to industry and FDA staff on marketing application
user fees for combination products. The guidance also describes how the
``barrier to innovation'' waiver provision under the prescription drug
user fee provisions of the Federal Food, Drug, and Cosmetic Act (the
act) may be applied to innovative combination products in the
infrequent situation where FDA requires the submission of two marketing
applications.
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for copies of this guidance to the
Office of Combination Products (HFG-3), 15800 Crabbs Branch Way,
Rockville, MD 20855, or FAX: 301-427-1935. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Mark D. Kramer, Office of Combination
Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch
Way, Rockville, MD 20855, 301-427-1934.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Application User Fees for Combination Products.''
In the Federal Register of September 28, 2004 (69 FR 57942), FDA issued
a notice of availability of a draft guidance document covering the same
topic.
As defined under 21 CFR 3.2(e), a combination product is a product
comprised of any combination of a drug and a device; a biological
product and a device; a drug and a biological product; or a drug,
device, and a biological product. Depending upon the type of
combination product, approval, clearance, or licensure may be obtained
through submission of a single marketing application, or through
separate marketing applications for the individual constituent parts of
the combination product. For most combination products, a single
marketing application is sufficient for the product's approval,
clearance, or licensure. In some cases, two marketing applications may
be submitted for a combination product when one application would
suffice. For example, a sponsor may choose to submit two applications
when one would suffice in order to receive some benefit from having two
applications. In other cases, FDA may determine that two marketing
applications are necessary.
In 1992, Congress passed the Prescription Drug User Fee Act
(PDUFA). PDUFA authorized FDA to collect fees from companies that
produce certain human drug and biological products. The Medical Device
User Fee and Modernization Act of 2002 amended the act to provide for
user fees for the review of device applications. When a company
requests approval of a new drug, device, or biological product prior to
marketing, it must submit an application along with a fee to support
the review process.
This document provides guidance to industry and FDA staff on
marketing application user fees for combination products. The guidance
document explains that combination products for which a single
marketing application is submitted, should be assessed the user fee
associated with that particular type of marketing application. The
document explains that if a sponsor chooses to submit two marketing
applications when one would suffice, a user fee for each application
would ordinarily be assessed. The document also explains that in the
infrequent situation where FDA requires two marketing applications for
a combination product, two application fees would ordinarily be
assessed. However, the guidance also describes how the PDUFA ``barrier
to innovation'' waiver provision may be applied to innovative
combination products for which FDA requires the submission of two
marketing applications. Such a waiver would provide a reduction in
application user
[[Page 20759]]
fees equivalent to the additional fee burden associated with the
submission of two marketing applications. This guidance does not
address how FDA should determine whether a single or multiple marketing
applications should be submitted for a combination product. Such
guidance is in development and will be provided separately for public
review and comment.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on application user fees for combination
products. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the guidance
at any time. Submit two paper copies of any mailed comments, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. The guidance and received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/oc/combination or by e-mailing the Office of
Combination Products at combination@fda.gov. Guidance documents are
also available on the Division of Dockets Management Internet site at
https://www.fda.gov/ohrms/dockets/default.htm.
Dated: April 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7947 Filed 4-20-05; 8:45 am]
BILLING CODE 4160-01-S
